SIS Graft and Traditional Repair in Vaginal Wall Prolapse

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00827528
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: Traditional correction of anterior vaginal wall prolapse; Procedure: Biologic Graft (SIS)	Phase 4

Detailed Description

The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: anatomic results of surgery; impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), sexual function with FSFI and possible complications

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair.
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SIS graft this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.	Procedure: Biologic Graft (SIS); Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.
Active Comparator: 2 this group will use a traditional repair on correction of anterior vaginal wall prolapse.	Procedure: Traditional correction of anterior vaginal wall prolapse; Traditional repair. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery.

Outcome Measures

Primary Outcome Measures

1. surgical anatomic results [one year]

Secondary Outcome Measures

1. impact on quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL); sexual function with FSFI; complications [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• anterior vaginal wall prolapse with poin Ba at least at +1;

• pre and postmenopausal patients

Exclusion Criteria:

• patients without surgical indication;

• infection;

• coagulopathy;

• gynecologic cancer;

• liver or kidney active diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of São Paulo	São Paulo	São Paulo/SP	Brazil	04025-001

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

• Study Chair: Manoel João BC Girão, PhD, Department of Gynecology, Federal University of São Paulo
• Principal Investigator: Paulo C Feldner Jr, MD, Department of Gynecology, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paulo Cezar Feldner Jr, PhD, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT00827528
• Other Study ID Numbers: SISAPI 01
• First Posted: Jan 22, 2009
• Last Update Posted: Mar 26, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Paulo Cezar Feldner Jr, PhD, Federal University of São Paulo: Pelvic Organ Prolapse; Surgical Treatment
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Mar 26, 2012